GUEST COLUMNISTS

• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

  A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

• EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

  The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

• PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?

  Few topics introduced by Annex 1 have generated as much discussion as pre-use post-sterilization integrity testing (PUPSIT). I share key considerations for cell and gene therapies.

• Is Your AI Model Trustworthy And Credible In GMP Processes?

  Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

• May 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• Setting The Tone For A Fill/Finish Engagement Program

  The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.

• FDA's Guidance On Cell And Gene CMC Codifies Flexibility

  The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.